Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery

NCT05861804 | Recruiting

• 1 other identifier: 2022.462.IRB1.182
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are:

• How will the total perioperative opioid consumption of the patients receiving RINB change?
• How will RINB effect the patients' numeric rating scores for pain in the postoperative 24-hour period?
• How will RINB effect the postoperative extubation times?
• How will RINB effect the length of intensive care unit (ICU) stays on the postoperative period?
• How will RINB effect the incidence of opioid related side effects? Participants will be divided in two groups:
• Block group will receive a RINB before the surgery.
• Control group will not receive any nerve block. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and ICU length of stay of the patients receiving RINB for minimal invasive heart surgery. The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.

Conditions

Minimal Invasive Heart Surgery; Rhomboid Intercostal Nerve Block

Keywords

rhomboid intercostal nerve block; minimal invasive heart surgery; cardiac anesthesia

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage

  24 hours post-surgery

Secondary Outcomes (4)

• Numeric rating scale scores for pain

  24 hours post-surgery

• Extubation time after surgery

  24 hours post-surgery

• Length of intensive care unit stay

  1 week follow up after surgery

• Opioid related side effects

  24 hours post surgery

Study Arms (2)

Block group

EXPERIMENTAL

Participants who will be receiving a rhomboid intercostal nerve block

Procedure: Rhomboid Intercostal Nerve Block

Control group

NO INTERVENTION

Participant who will not be receiving any intervention

Interventions

Rhomboid Intercostal Nerve Block PROCEDURE

Before the induction of general anesthesia, under aseptic conditions, rhomboid intercostal nerve block will be performed with a single dose of 20 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.

Block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the age of 18-80 undergoing minimal invasive heart surgery

You may not qualify if:

• Allergy to local anaesthetics
• Chronic opioid use history
• Patients with psychiatric disorders
• Patients who are not open to communication
• Patients with chronic organ failure
• Patients that do not give consent
• Patients that need emergency surgery within the first 24 hours of the initial surgery

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Study Officials

• Kamil Darçın, MD

  Koç University

  STUDY DIRECTOR

Central Study Contacts

Kamil Darçın, MD

CONTACT

+90 505 589 50 99; kdarcin@ku.edu.tr

Yasemin Sincer, MD

CONTACT

sincer.yasemin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: June 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting from 6 months after publication for 5 years
• Access Criteria: no access criteria

Locations

TU (1)